Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma (AADI)
This study is currently recruiting participants.
Verified January 2013 by Aurolab
Sponsor:
Aurolab
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT01401088
First received: July 20, 2011
Last updated: January 2, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory glaucoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma |
Device: Artificial drainage implant |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Aurolab:
Primary Outcome Measures:
- Intra Ocular Pressure (IOP) [ Time Frame: One year ] [ Designated as safety issue: No ]Mean Intraocular pressure (IOP) reduction from pre operative IOP
Secondary Outcome Measures:
- Success rate [ Time Frame: one year ] [ Designated as safety issue: No ]Success rate (defined as Inraocular pressure (IOP) of 5mmHg to 20 mmHg and at least a 20% reduction in IOP without visually devastating complications or additional glaucoma surgery)
- Number of patients with adverse events as a measure of safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]to assess the incidence of post operative adverse events
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Artificial drainage implant
Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.
|
Device: Artificial drainage implant
Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
Other Name: AADI
|
Detailed Description:
Aurolab Artificial Drainage Implant is a non resistant tube device based on Baerveldt implant. It reduces intra ocular pressure by draining aqueous from anterior chamber into sub-conjunctival space formed around base of the implant. Reduction of intraocular pressure prevents further damage to optic nerve and functional visual field loss in advanced refractory glaucoma.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years of age or older
- Significant optic nerve damage and visual field loss due to glaucoma in eligible eyes
- Eligible eyes is considered at high risk of failure/complication following conventional filtering surgery
- Eyes with uncontrolled glaucoma with prior history of Filtering surgery/Uveitic/ Neovascular/Developmental glaucomas
- IOP≥18 mm of Hg with or without anti glaucoma medications
- If taking glaucoma medications, stable dose for 6 weeks
Exclusion Criteria:
- Age<18 years
- Eyes with uncontrolled glaucoma expected to have favorable post-operative outcome by conventional trabeculectomy
- Corneal abnormalities that would preclude accurate IOP readings
- Uncontrolled systemic diseases
- Endothelial cell count<1800cells/mm
- Any other active ocular disease,(active uveitis, ocular infection)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401088
Contacts
| Contact: Dr. Prashanth Ranganath, MBBS., MS., | +91 452 4356100 ext 118 | loweriop@gmail.com |
| Contact: Mr.S.Karthi Kumar, M.Pahrmacy | +91 452 4356100 ext 229 | crd@aurolab.com |
Locations
| India | |
| Aravind Eye Hospital | Recruiting |
| Madurai, Tamilnadu, India, 625020 | |
| Contact: Mr. S.Karthi Kumar, M. Pharmacy +91 452 3096100 ext 229 crd@aurolab.com | |
| Contact: Ms. Sophia , M.Sc +91 452 4356100 ext 364 clinicaltrials@aravind.org | |
| Principal Investigator: Dr. Prashanth Ranganath, MBBS., MS., | |
Sponsors and Collaborators
Aurolab
Investigators
| Principal Investigator: | Dr. Prashanth Ranganath, MBBS., MS., | Aravind Eye Hospital, Madurai |
More Information
No publications provided
| Responsible Party: | Aurolab |
| ClinicalTrials.gov Identifier: | NCT01401088 History of Changes |
| Other Study ID Numbers: | 1PN1011049 |
| Study First Received: | July 20, 2011 |
| Last Updated: | January 2, 2013 |
| Health Authority: | India: Ministry of Health |
Keywords provided by Aurolab:
|
patient with refractory glaucoma |
Additional relevant MeSH terms:
|
Glaucoma Ocular Hypertension Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013